PHARMACOLOGICAL CLASSIFICATION: 5.7 Antihistaminics, anti-emetics and antivertigo preparations.
PHARMACOLOGICAL ACTION : ASIC tablets are enteric coated tablets consisting of a combination of Dicyclomine hydrochloride, an anticholinergic which has antispasmodic and anaesthetic effects on the gastro-intestinal tract similar to, but weaker than that of atropine, and Doxylamine succinate which imparts antihistaminic actions to the preparation and also gives it a sedative effect.
Pyridoxine hydrochloride has been added to enhance the anti-emetic effects and as a dietary supplement.
INDICATIONS: ASIC tablets are used in the control of nausea and vomiting associated with pregnancy.
CONTRA-INDICATIONS: ASIC is contra-indicated during acute attacks of asthma. It should not be administered to epileptics as it may precipitate fits.
WARNINGS: The use of this medicine leads to drowsiness which is aggravated by the simultaneous intake of alcohol and other CNS depressants. ASIC should not be administered concurrently with monoamine oxidase inhibitors.
DOSAGE AND DIRECTIONS FOR USE: 2 tablets at bedtime, 1 additional tablet before rising and another in mid-afternoon in severe cases.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Dicyclomine hydrochloride may cause dryness of the mouth, difficulty in swallowing and talking, thirst, dilation of the pupils with loss of accommodation and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and urinary urgency, difficulty and retention, as well as reduction in the tone and motility of the gastro-intestinal tract leading to constipation. Occasionally vomiting, giddiness and staggering may occur. Retrosternal pain may occur due to increased gastric reflux.
Toxic doses may cause tachycardia, rapid respiration, hyperpyrexia, and CNS stimulation marked by restlessness, confusion, excitement, paranoid and psychotic reactions, hallucinations and delirium, and occasionally seizures and convulsions. A rash may appear on the face or upper trunk. In severe intoxication, central stimulation may give way to CNS depression, coma, circulatory and respiratory failure, and death.
Doxylamine succinate may cause drowsiness, lassitude, dizziness and inco-ordination. Other side-effects include gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite, and epigastric pain, blurred vision, difficulty in micturition, dysuria, dryness of the mouth, and tightness of the chest, hypotension, muscular weakness, tinnitus, euphoria, and occasionally headache.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Mostly drowsiness. In severe overdosage the stomach should be emptied by aspiration and lavage. Activated charcoal may be given. The patient should be taken to the nearest hospital for treatment.
IDENTIFICATION: White enteric coated tablets.
PRESENTATION: Packs of 30 tablets.
STORAGE INSTRUCTIONS: Store in a cool, dry place below 25°C.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: G/5.7/80
NAME AND BUSINESS ADDRESS OF APPLICANT: Pharmaceutical Enterprises (Pty) Ltd
Howard Studios, Howard Drive, Pinelands 7405
DATE OF PUBLICATION OF THIS PACKAGE INSERT: October 1993
Current: March 2004 Source: Pharmaceutical Industry